Piperaquine Granule Formulation Relative Bioavailability and Food Effect Study in Healthy Volunte… (NCT05930782) | Clinical Trial Compass
CompletedPhase 1
Piperaquine Granule Formulation Relative Bioavailability and Food Effect Study in Healthy Volunteers.
Tanzania60 participantsStarted 2023-08-14
Plain-language summary
This trial aims to characterise the pharmacokinetic (PK) profile and estimate drug exposure of a single oral dose of piperaquine (PQP) in a dispersible granule formulation compared to the PQP hard tablet formulation in the fasted state (Part 1), to advise the selection of dose when the PQP granule formulation is administered in a fed state in healthy adult participants. Part 2 will assess the effect on different types of meal composition on the PK of a single dose of PQP granule formulation in healthy adult participants.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. Female or Male aged ≥18 years to ≤55 years at the date of signing informed consent.
✓. Ability to provide written, personally signed, and dated informed consent to participate in the trial, in accordance with the ICH Good Clinical Practice (GCP) and applicable regulations, before any trial-related procedures.
✓. An understanding, ability, and willingness to fully comply with trial procedures and restrictions.
✓. Female participants must agree to follow contraceptive requirements as indicated in Section 13.2.2, from at least 30 days prior to first dosage to 16 weeks after last dosage.
✓. Agrees not to donate sperm or ova from the time of the first administration of trial medication until twelve weeks after the end of the systemic exposure of the trial drug.
✓. Participants must have a body weight of 50 kg or greater and a BMI between 18.0 kg/m² - 30.0 kg/m² (inclusive) at screening.
✓. Satisfactory medical assessment with no clinically significant or relevant abnormalities as determined by; medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG) and clinical laboratory evaluation that is reasonably likely to interfere with the participant's participation in or ability to complete the trial as assessed by the Investigator.
Exclusion criteria
✕. Prior screen failure or randomisation in this trial. NOTE: Participants who initially failed due to temporary non-medically significant issues are eligible for re-screening once the cause has resolved.
✕. Female participant who is pregnant (from history, examination or confirmed by a positive serum pregnancy test at screening and/or on Day -1) or breastfeeding.
What they're measuring
1
Relative Bioavailability (Frel) of the Maximum Observed Plasma Concentration (Cmax) of the PQP Dispersible Granule Compared to the PQP Hard Tablet in the Fasted State (Frel Cmax).
Timeframe: Plasma samples taken pre-dose -0.5 hours, then 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, Day 5, Day 8, Day 15, Day 22 and Day 30 post-dose.
2
Relative Bioavailability (Frel) of the Area Under the Plasma Concentration-time Curve From Time Zero to 72h Hours (AUC0-72h) of the PQP Dispersible Granule Compared to the PQP Hard Tablet in the Fasted State (Frel AUC0-72h).
Timeframe: Plasma samples taken pre-dose -0.5 hours, then 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, Day 5, Day 8, Day 15, Day 22 and Day 30 post-dose.
3
Relative Bioavailability (Frel) of the Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t) of the PQP Dispersible Granule Compared to the PQP Hard Tablet in the Fasted State (Frel AUC0-t).
Timeframe: Plasma samples taken pre-dose -0.5 hours, then 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, Day 5, Day 8, Day 15, Day 22 and Day 30 post-dose.
4
Relative Bioavailability (Frel) of the Area Under the Plasma Concentration-time Curve From Time Zero to 168 Hours (AUC0-168h) of the PQP Dispersible Granule Compared to the PQP Hard Tablet in the Fasted State (Frel AUC0-168h.
Timeframe: Plasma samples taken pre-dose -0.5 hours, then 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, Day 5, Day 8, Day 15, Day 22 and Day 30 post-dose.
5
Relative Bioavailability (Frel) of the Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of the PQP Dispersible Granule Compared to the PQP Hard Tablet in the Fasted State (Frel AUC0-∞).
✕. Male participants with a female partner(s) who is (are) pregnant or lactating at screening and/or on Day -1, or is (are) expected to be during the trial period.
✕. Has a mental incapacity or language barriers precluding adequate understanding, co-operation, or compliance with the trial requirements.
✕. Unable or unwilling to follow a standardised diet and meal schedule or unable to fast, as required during the trial.
✕. Has milk intolerance.
✕. Unable to swallow tablets.
✕. Has veins on either arm that are unsuitable for intravenous puncture or cannulation (e.g., veins that are difficult to locate, or a tendency to rupture during puncture).
Timeframe: Plasma samples taken pre-dose 0.5 hours, then 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, Day 5, Day 8, Day 15, Day 22 and Day 30 post-dose.